Break-Point: FDA Committee Votes To Restrict Quinolones, But Does Not Endorse Disability Syndrome

An FDA advisory committee review of quinolone antibiotic safety focused on a very old safety issue – but points to a new era in antibiotic development, and restricted use models.

One way of describing the Nov. 5 meeting of FDA’s Antimicrobial Drugs and Drug Safety & Risk Management Advisory Committees focused on a long-standing safety concern with a very widely used class of drugs.

Critics of the quinolone class—including Public Citizen—have advocated for labeling changes and product withdrawals for two decades, asserting that the...

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